Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

NCT ID: NCT00562471

Last Updated: 2007-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-01-31

Brief Summary

The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Detailed Description

Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Conditions

Myoma

Keywords

adhesions; gynecologic surgery; laparoscopy; laparotomy; polyethylene glycol; hydrogel; Adhesions following gynecologic surgery to remove myomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Adhesion Prevention Gel Arm

Group Type: EXPERIMENTAL

Adhibit Adhesion Prevention Gel

Intervention Type: OTHER

A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.

2

Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure)

Group Type: OTHER

Standard of Care Comparator

Intervention Type: OTHER

standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure

Interventions

Adhibit Adhesion Prevention Gel

A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.

Intervention Type: OTHER

Standard of Care Comparator

standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure

Intervention Type: OTHER

Other Intervention Names

CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel

Eligibility Criteria

Inclusion Criteria

Preoperatively, subjects must have had:

• Been scheduled for myomectomy via laparotomy or laparoscopy.
• Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
• Been >=18 years of age.
• Provided voluntary written informed consent.
• Been willing to comply with all aspects of the treatment and evaluation schedule.

Intra-operatively, subjects must have had:

• Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.

Exclusion Criteria

Preoperatively, subjects must not have had:

• Been pregnant.
• Had a pelvic malignancy.
• Had acute pelvic inflammatory disease.
• Had an immune compromised condition.
• Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
• Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.

Intra-operatively, subjects must not have had:

• Had a pelvic malignancy.
• Had a pelvic or abdominal infection.
• Had acute pelvic inflammatory disease.
• Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Angiotech Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Liselotte METTLE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Univ. Clinics of Schleswig-Holstein

Locations

St. Joseph's Health Centre

Toronto, Ontario, Canada

Klinik für Minimal Invasive Chirurgie

Berlin, , Germany

Universitätsklinikum Giessen

Giessen, , Germany

Univ. Clinics of Schleswig-Holstein

Kiel, , Germany

Bethesda Krankenhaus Wupperta

Wuppertal, , Germany

St. Elizabeth Hospital

Curaçao, , Netherlands Antilles

Countries

Canada; Germany; Netherlands Antilles

References

Mettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R. A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Hum Reprod. 2008 May;23(5):1093-100. doi: 10.1093/humrep/den080. Epub 2008 Mar 17.

Reference Type: DERIVED

PMID: 18346996 (View on PubMed)

Other Identifiers

ADH-02-1.1

Identifier Type: -

Identifier Source: secondary_id

ADH-02-1.2

Identifier Type: -

Identifier Source: secondary_id

ADH-02-1.3

Identifier Type: -

Identifier Source: secondary_id

ADH-02-1

Identifier Type: -

Identifier Source: org_study_id